FDA Issues Guidance on Medical Device Data Systems

The Food and Drug Administration has issued draft guidance informing industry that the agency does not intend to enforce compliance with the regulatory controls that apply to medical device data systems, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients.

In 2011, FDA issued a regulation down-classifying medical device data systems. Since that time, FDA has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public, writes Bakul Patel, senior policy advisor in FDAs Center for Devices and Radiological Health, in a June 20 blog.